Human Genome Sciences and GlaxoSmithKline announced that Benlysta (belimumab, formerly LymphoStat-B) has met the primary endpoint in BLISS-52, a pivotal Phase 3, 52-week, multicenter, double-blind, placebo-controlled, superiority trial in patients with serologically active systemic lupus erythematosus (SLE). The primary efficacy endpoint was the patient response rate at Week 52, as defined by: (1) a reduction from baseline of at least 4 points on the SELENA SLEDAI disease activity scale (which indicates a clinically important reduction in SLE disease activity); (2) no worsening of disease as measured by the Physician’s Global Assessment (worsening defined as an increase of 0.3 points or more from baseline); and (3) no new BILAG A organ domain score (which indicates a severe flare of lupus disease activity) and no more than one new BILAG B organ domain score (which would indicate a moderate flare of disease activity). Study results showed Benlysta plus standard of care achieved a clinically and statistically significant improvement in patient response at Week 52 compared with standard of care alone. Additionally, a greater percentage of patients receiving Benlysta achieved a clinically meaningful reduction in steroid dose.
Benlysta is a human monoclonal antibody drug that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator (BLyS). BLyS is a naturally occurring protein required for the development of B-lymphocyte cells into mature plasma B cells that produce antibodies. In SLE, elevated levels of BLyS are believed to contribute to the production of autoantibodies.